Beevers Cannulaide Respirator Recalled for Improper Pouch Seal
Beevers Manufacturing recalled Cannulaide respirators due to improper pouch seals that could affect device shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to potential shelf-life reduction due to packaging defects without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Beevers Manufacturing & Supply, Inc. is recalling Cannulaide, Model 101, 102, and 103 respirators. These devices are die-cut hydrocolloid-coated polyurethane films with an integral hook strip used to secure nasal interfaces on infants. The recall was initiated in May 2008 because of an improper seal on the product packaging.
The improper seal of the Cannulaide's package could potentially affect the device's shelf life. The recall covers 16,575 units total, with 15,625 units distributed in the United States and 950 units distributed outside the US. Distribution included specific US states and countries such as Canada, France, Japan, the Netherlands, and the United Kingdom.
The affected lots are CA 101 (Lot 54219), CA 102 (Lot 52834), and CA 103 (Lot 53813). Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is…
- Manufacturer
- Beevers Manufacturing & Supply, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- CA 101: Lot 54219
- CA 102: Lot 52834
- CA 103: Lot 53813
Distribution
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